The goal of this clinical trial is to investigate a new approach for treating large uveal
melanomas, a type of eye cancer. The study aims to determine the effectiveness of using
intra-arterial melphalan, a chemotherapy drug, to reduce tumor thickness, allowing for
subsequent radiation therapy using a Ru-106 plaque.
The main questions this trial seeks to answer are:
- Can intra-arterial melphalan effectively reduce the thickness of large uveal melanomas?
- Is the combination of intra-arterial melphalan and brachytherapy a safe and effective
treatment option for these tumors?
Participants enrolled in the trial have clinically diagnosed choroidal melanoma with tumor
thickness equal to or greater than 8.00 mm. They will undergo a procedure where the
chemotherapy drug is injected directly into the blood vessels that supply the tumor. After a
few weeks, they will receive the radiation treatment using a small device placed on the eye.
Throughout the trial, participants will have different tests to monitor the tumor and their
vision, such as ultrasound scans, pictures of the inside of the eye, and a test called
electroretinography (ERG) to check the function of the retina. These tests will be done at
the start of the trial and at 1, 3, and 6 months later to track the progress of the
treatment.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Hospital das Clínicas de Ribeirão Preto
Collaborator:
Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo